A Must In Clinical Development Collaborations: Identity Trust

Globalism
is forcing the bio-pharmaceutical
industry to find new ways to work across vast enterprise and
geographical
boundaries. Companies develop products in
cooperation and
form coalitions to improve Research
&
Development.
Clinical
trials
are outsourced to Clinical
Research
Organizations,
often working with researchers and sites across
the globe. The computer software products that
coordinate and integrate all the activities involved in the
management of a health-care facility by the Clinic Management
Systems.

With
advancement of technologies, cloud computing made it all possible by
allowing applications and their frequent updates to be accessed
centrally, at a fraction of the expenditure and time required in the
past.

But
everything has it pros and cons; relying on the cloud exposes
organizations to data theft, significant challenges to business
security, and regulatory compliance.

So
the fact is that identity trust is foundational to clinical
development platforms such as TransCelerate's Shared Investigator
Platform (SIP) and Merck's EngageZone. It allows all of their
participants to collaborate efficiently and securely by convincing
that the identity accessing a portal and the valuable information it
contains does not belong to someone else. And identity trust soothes
the burden on clinical investigators by allowing use of a single
identity that can be recognized across business, government and
academic attributes.

EngageZone ,SIP and other
platforms support collaboration by allowing clinicians, researchers,
patient groups, executives, and others participants in drug
development to access data and sign and exchange documents. With the
potential of thousands of participants from across the globe,
identity trust is a must.

The SIP became operational
earlier this year, and EngageZone has 60,000+ participants. Each
needs those accessing the platforms to use identity credentials that
are complaint with the global SAFE-BioPharma.

SAFE-BioPharma is invisible
and operates in the background; not unlike lubricant that keep cars
performing their best.

Pharma IT executives created
SAFE-BioPharma as a way to assure identity trust across the Internet.
They chose an approach requiring identity credentials to be issued
following a process that proves an individual's legal identity
through presentation and review of documentation and/or biometric
evidence. The process is connected with national and international
laws, regulations and standards. Because of this alliance, identity
credentials compliant with the SAFE-BioPharma standard can be trusted
by other entities, including pharmaceutical and health-care
companies, US Government agencies and companies in other industries.

So this is one credential for
many trials. The SAFE-BioPharma identity credential can be used for
most other trials from the same and other sponsors. There would be no
multiple user names and passwords. SAFE-BioPharma compliant
credential will be a single identity. Take it as a personal passport
to the Internet; one trusted credential identifying you for all
trials.

Individuals with a specific
type of SAFE-BioPharma identity credential are able to apply digital
signatures to electronic documents. To mention its the single
strongest form of electronic signature in existence.

Being based on Cryptography,
the signatures are legal binding and can't be defied by the
signatory. They provide the strongest proof of the person who gave
the signature, and they safeguard the document by unveiling when a
change to the signed document is made.

When clinicians, researchers
and others participating in collaborative clinical development
platforms learn that the identity credentials they've taken are
SAFE-BioPharma compliant they'll be able to operate without the
hassle of managing too many cyber identities. It would make the
entire development process more efficient. And it's all based on
identity trust.

The President and CEO of
SAFE-BioPharma Association is Mollie Shields-Uehling.

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